FDA Inspection
OPS International IncOPS International Inc – FDA Inspection, Dec 4, 2014
Record Details
This FDA Inspection record concerns OPS International Inc, with an inspection on December 4, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- OPS International Inc
- Inspection Date
- December 4, 2014
- Product Type
- Drugs
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ID · b29587f5-c235-4fec-9927-7852335d9f5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 907206
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of OPS International Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2026 | Not classified | Florida District Office | Drug Quality Assurance |
| August 8, 2025 | OAI | Florida District Office | Drug Quality Assurance |
| May 29, 2024 | OAI | Drug Quality Assurance | |
| April 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 21, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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